A diverse pipeline of innovative topical skin medications, based on proprietary microencapsulation technology

EPSOLAY®

(microencapsulated benzoyl peroxide cream, 5%)
Inflammatory Lesion of Rosacea

NDA set to file 1H/2020

TWYNEO®

(microencapsulated benzoyl peroxide, 3% and microencapsulated tretinoin, 0.1%)
Acne Vulgaris

NDA set to file 2H/2020

Novel Drug Delivery Technology

EPSOLAY®

EPSOLAY®

Benzoyl peroxide is known to be a treatment for rosacea, but causes significant irritation. Our silica-based microencapsulation delivery system creates a silica barrier between benzoyl peroxide crystals and the skin, and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide, thereby making the drug tolerable to rosacea-affected skin. Our solution also alters the release profile of the drug substance to reduce skin irritation while maintaining efficacy.

Moreover, the safety and tolerability profile of EPSOLAY® was similar to that of the vehicle.

PHASE III DATA

Not an actual patient – actor portrayal

TWYNEO®

TWYNEO®

TWYNEO® is a novel non-antibiotic cream designed to be tolerable and highly effective. It is the first acne treatment that contains a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide. While major challenges were the instability of tretinoin in the presence of benzoyl peroxide and irritation, encapsulation allows stabilization and is also expected to contribute to patient compliance.

The silica microcapsule protects tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing commercial shelf-life. The silica shell also creates a barrier between the drug substances and the skin and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide and tretinoin, thereby increasing the tolerability of TWYNEO® on acne-affected skin.

Opportunity exists for a shift from prescribing tretinoin and existing combinations to prescribing TWYNEO®.

PHASE III DATA

Not an actual patient – actor portrayal

Generic Products

In addition to drug products based on our proprietary delivery system, we have a portfolio of generic product candidates with favorable commercial agreements that supplement our branded pipeline and potentially make a meaningful contribution to operating income.

ivermectin cream, 1%

(RLD: SOOLANTRA®)

Tentative Approval as of January 2018

acyclovir cream, 5%

(RLD: ZOVIRAX®)

Approval & Sales as of February 2019

5-fluorouracil cream, 5%

(RLD: EFUDEX®)

BE Results in Q4 2019

Additional R&D

In addition to advancing our lead product candidates, we are also engaged in the formulation and pre-clinical development of early stage innovative product candidates for both current focus indications, such as acne and rosacea, and for other dermatological indications.